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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012651
Receipt No. R000014789
Scientific Title Genetic analysis for schizophrenia and mood disorders
Date of disclosure of the study information 2014/01/06
Last modified on 2020/06/25

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Basic information
Public title Genetic analysis for schizophrenia and mood disorders
Acronym Genetic analysis for schizophrenia and mood disorders
Scientific Title Genetic analysis for schizophrenia and mood disorders
Scientific Title:Acronym Genetic analysis for schizophrenia and mood disorders
Region
Japan

Condition
Condition Schizophrenia, mood disorders and healthy controls.
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The aim of this study is to clarify the pathology of schizophrenia and mood disorders by genetic analysis to investigate single nucleotide polymorphisms and promoter methylation.
Basic objectives2 Others
Basic objectives -Others Clinical characteristics
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Assessments of clinical symptoms, single nucleotide polymorphisms and promoter methylation in comparison with those of schizophrenia and mood disorders.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Drawing blood, questionnaires and medical interviews for schizophrenia patients, mood disorder patients and healthy controls.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with diagnoses of schizophrenia and mood disorders of age 16 and over, who are inpatients or outpatients, and healthy controls who volunteer to participate in the study after receiving an adequate explanation of it.
Key exclusion criteria Those with severe physical illness, people judged not suitable by doctor
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Kazuhiro
Middle name
Last name Kondo
Organization The Jikei University School of Medicine
Division name Department of Virology
Zip code 105-8461
Address 3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL 03-3433-1111
Email kkondo@jikei.ac.jp

Public contact
Name of contact person
1st name Kazuhiro
Middle name
Last name Kondo
Organization The Jikei University School of Medicine
Division name Department of Virology
Zip code 1058461
Address 3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL 03-3433-1111
Homepage URL
Email kkondo@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

Funding Source
Organization MEXT
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) Japan Tobacco inc., Virus Ikagaku Kenkyusho Inc.

IRB Contact (For public release)
Organization the Ethics Committee of the Jikei University School of Medicine
Address 3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo
Tel 03-3433-1111
Email rinri@jikei.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京慈恵会医科大学附属病院(東京都)、東京慈恵会医科大学附属柏病院(千葉県)、医療法人常心会川室記念病院(新潟県)

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 06 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2013 Year 11 Month 29 Day
Date of IRB
2013 Year 10 Month 07 Day
Anticipated trial start date
2014 Year 01 Month 06 Day
Last follow-up date
2021 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Case control sampling

Management information
Registered date
2013 Year 12 Month 21 Day
Last modified on
2020 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014789

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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